Patients will be centrally allocated in a randomized fashion (3:1:1:3) to receive either:
Arm 1: Nemvaleukin and pembrolizumab combination therapy Arm 2: Pembrolizumab monotherapy (enrollment completed) Arm 3: Nemvaleukin monotherapy (enrollment completed) Arm 4: Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.
Inclusion Criteria:
- Patient is female and ≥18 years of age.
- Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous,
endometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal
cancer.
- Patient has platinum-resistant/refractory disease, defined as disease progression
within 180 days following the last administered dose of platinum therapy beyond
first-line setting (resistant) or lack of response or disease progression while
receiving the most recent platinum-based therapy (refractory). Patient must have
progressed radiographically on or after their most recent line of anticancer therapy.
- Patient must have received at least 1 prior line of systemic anticancer therapy in the
platinum sensitive setting, and no more than 5 prior lines of systemic anticancer
therapy in the platinum-resistant setting. Patient must have received at least 1 line
of therapy containing bevacizumab.
- Patient has at least one measurable lesion that qualifies as a target lesion based on
RECISTv1.1.
- Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifying
archival tumor tissue.
Exclusion Criteria:
- Patient has primary platinum-refractory disease or primary platinum resistance,
defined as disease progression during first-line platinum-based therapy (refractory)
or disease progression <3 months after completion of first-line platinum-based therapy
(resistant).
- Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcoma
subtype.
- Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumor
with low malignant potential (ie, borderline or low-grade serous tumor).
- Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis)
of ≥500 mL within 4 weeks of first dose of study drug.
- Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had
exposure, including intralesional, to IL-12 or analogs thereof.
- Patient has prior exposure to any anti-PD1/PD-L1 therapy.
Other Female Genital
Ovary